Intravenous Tranexamic Acid During Rhytidectomy

Bleeding Clinical Trial

Official title:

Effects of Intravenous Tranexamic Acid During Rhytidectomy - a Randomized, Controlled, Double-blind Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03970213
• Other study ID #: GGPS19-01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 30, 2019
• Est. completion date: August 30, 2019

Study information

• Verified date: May 2019
• Source: Glasgold Group Plastic Surgery
• Contact: Mark J Glasgold, MD
• Phone: 732-846-6540
• Email: mglasgold[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted.

Description:

This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is rated on a scale of mild, moderate, or severe and given a score of 1-3. Postoperative ecchymosis and edema are subjectively rated by both patient and surgeon on postoperative days 1, 6, and 9 using a similar mild/moderate/severe scale and scored 1-3, respectively. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Undergoing rhytidectomy surgery at Glasgold Group Plastic Surgery

Exclusion Criteria:

• History of bleeding disorder, history of thromboembolic events, history of seizure, active use of oral contraceptive pills or hormone replacement therapy, participant preference

Related Conditions & MeSH terms

• Bleeding
• Bruising Face
• Swelling Lips & Face

Intervention

Drug:
• Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
IV TXA given during surgery
• Normal Saline 0.9% Infusion Solution Bag
IV saline given during surgery

Locations

Country	Name	City	State
United States	Glasgold Group Plastic Surgery	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Glasgold Group Plastic Surgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative bleeding	Subjective measure of intraoperative blood loss (mild, moderate, or severe)	Surgical time
Primary	Postoperative ecchymosis	Subjective measure of bruising rated as mild, moderate, or severe	Postoperative day 1
Primary	Postoperative ecchymosis	Subjective measure of bruising rated as mild, moderate, or severe	Postoperative day 6
Primary	Postoperative ecchymosis	Subjective measure of bruising rated as mild, moderate, or severe	Postoperative day 9
Primary	Postoperative edema	Subjective measure of swelling rated as mild, moderate, or severe	Postoperative day 1
Primary	Postoperative edema	Subjective measure of swelling rated as mild, moderate, or severe	Postoperative day 6
Primary	Postoperative edema	Subjective measure of swelling rated as mild, moderate, or severe	Postoperative day 9
Secondary	Postoperative hematoma/seroma	Documentation of any postoperative collections seen during the first 10 days following surgery	10 days postoperative
Secondary	Complications	Documentation of any surgical or postoperative complications	10 days postoperative